Elecsys HCG STAT 07229569190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630940417), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2018Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 MALE PATIENT TESTED FOR ELECSYS HCG + B (HCG + B) AND ELECSYS HCG STAT (HCG STAT) ON A COBAS E801 MODULE. BASED ON THE DATA PROVIDED, THE HCG STAT RESULTS ARE A REPORTABLE MALFUNCTION. THE INITIAL HCG STAT RESULT FROM THE E801 MODULE WAS 2.96 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE SIEMENS METHOD AND THE HCG RESULT WAS 10.7 MIU/ML. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND TESTED ON AN E801 MODULE AT THE INVESTIGATION SITE. THE HCG STAT RESULT WAS 2.61 MIU/ML WHICH CORRESPONDED TO THE CUSTOMER'S RESULT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER USED AT THE CUSTOMER SITE WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE HCG STAT REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 319823 WITH AN EXPIRATION DATE OF 31-JUL-2019. CALIBRATION AND QC AT THE INVESTIGATION WAS ACCEPTABLE. BASED ON THE DATA AVAILABLE, A REAGENT ISSUE WAS NOT IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047287 ↗